Immediate Loading a Histological Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-03

Study Completion Date

2020-02-28

Brief Summary

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Twelve participants with edentulous alveolar crests in the distal portion of the arches will be included in the study. At least two implant sites will be identified in each patient and will be sub-prepared with drills or sonic instruments. One site will be used as a test and one as a control where experimental mini-implants will be installed. Reconstructive surgical procedures will be applied at the biopsy sites.

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Detailed Description

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Objective: - To evaluate histologically the influence of the functional load on implants, both immediate and delayed.

Material and methods: 12 participants with edentulous alveolar crests in the distal portion of the arches will be included in the study. At least two implant sites will be identified in each patient and will be sub-prepared with drills or sonic instruments to obtain a high degree of torque to ensure optimum primary stability. At least one site will be used as a test and one as a control where experimental mini-implants will be installed. Test sites will be loaded immediately. The control sites will remain unloaded. After 2 months, mini-implants will be recovered as planned for each group. Reconstructive surgical procedures will be applied at the biopsy sites, if necessary, using autologous bone or bone substitutes and membranes. Standard implants will be installed during the same surgical session and, after 2 months, the planned prosthesis will be performed. Patients will be followed for at least 2 years for evaluation and intervention, if necessary.

Biopsies will be included in resin to obtain wear cuts for histomorphometric analysis. The bone histomorphometry will be evaluated and statistical analysis will be carried out.

Conditions

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Edentulous Alveolar Ridge

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Split mouth, At least one site will be used as a test and one as a control where experimental mini-implants will be installed.

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

One of the researchers , neither involved in the selection of the patients nor in the surgical and prosthetic treatment, will carry out electronically the randomization (randomization.com). Will be prepared sealed opaque envelopes and opened at the time of surgery.

Study Groups

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Immediate implant Loading

Immediate loading is defined as the placement of the implant and immediate prosthetic restoration

Group Type EXPERIMENTAL

immediate loading

Intervention Type PROCEDURE

The participants will be assigned to immediate or delayed functional loading groups. In each participant, edentulous areas with adequate thickness of the alveolar bone crest will be identified and at least two sites will be identified for implant installation. All implant recipient sites will be sub-prepared to allow good stability of the implants. Experimental mini-implants (Sweden \& Martina, Due Carrare, Padova, Italy), 3.5 mm in diameter and with an intraosseous portion of 4 mm in length will be installed.

Immediate loading group - A prosthetic component will be applied over the trial implants. Impressions will be taken and a crown / bridge will be provided to patients in one day.

non implant loading

Intervention Type PROCEDURE

Control implants will receive a healing screw and will remain unloaded

non implant loading

there is not immediate prosthetic restoration

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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immediate loading

The participants will be assigned to immediate or delayed functional loading groups. In each participant, edentulous areas with adequate thickness of the alveolar bone crest will be identified and at least two sites will be identified for implant installation. All implant recipient sites will be sub-prepared to allow good stability of the implants. Experimental mini-implants (Sweden \& Martina, Due Carrare, Padova, Italy), 3.5 mm in diameter and with an intraosseous portion of 4 mm in length will be installed.

Immediate loading group - A prosthetic component will be applied over the trial implants. Impressions will be taken and a crown / bridge will be provided to patients in one day.

Intervention Type PROCEDURE

non implant loading

Control implants will receive a healing screw and will remain unloaded

Intervention Type PROCEDURE

Other Intervention Names

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implant surgery, prosthesis control site

Eligibility Criteria

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Inclusion Criteria

* Adult participants (≥25 years of age) with the need of at least two implants to replace teeth of the jaw will be included.
* Natural antagonist teeth have to be present both at test and control sites to guarantee occlusal contacts

Exclusion Criteria

* untreated rampant caries or uncontrolled periodontal disease of the remaining teeth
* diabetes not controlled diabetes or any other systemic or local disease that could compromise postoperative healing and / or osseointegration
* need for systemic corticosteroids or any other medication that could compromise postoperative healing and / or osseointegration
* inability or unwillingness to return to follow-up not likely to be able to comply with the study procedures according to the judgment of the investigators
* pregnancy

Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes